# K053197: Trufill DCS Orbit Detachable Coil System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Dec 15, 2005 after 29 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123560: Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem (2013), 0 descendants of its own

## Indications for use
The TRUFILL DCS ORBIT TM Detachable Coil is indicated for embolizing certain intracranial aneurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: I) very high-risk for management by traditional operative techniques 2) inoperable and for embolizing other vascular malformations such as arteriovenous mallonnations and arteFioveCfous tistulaC of the neurovasculature. The TRUFILL DCS ORBII M T Detachable Coil is also intended for arterial and venous enbolizations in the peripheral vasculature. The TRUFILLJ' DCS SyTinge is indicated for use with the TRUPILL> family of Detachable Coils.

Source page: https://510kreport.com/device/K053197
Methodology: https://510kreport.com/methodology